Back to resultsPost Marketing Trial for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard To Heal Wounds
Primary Purpose
Wounds
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ActiGraft
Sponsored by
About this trial
This is an interventional treatment trial for Wounds focused on measuring Chronic, Ulcer, Lower extremity, DFU, VLU
Eligibility Criteria
Inclusion Criteria:
- Subject is ≥18 years of age
- Patient with a chronic lower extremity ulcer (i.e DFU, VLU, …)
- Ulcer duration >30 days.
- Ulcer size decreased in less than 30% in the 14 days prior to enrollment, while treated with standard of care (or advanced treatment)
- Subject must be willing to comply with the protocol including having blood drawn to create the ActiGraft
- Subject can read and understand the Informed Consent form
Exclusion Criteria:
- Presence of active underlying osteomyelitis.
- Known malignancy in the reference wound bed or margins of the wound
- Cannot withdraw blood in the required amount technically.
- Subject is receiving (i.e., within the past 30 days) systemic steroids (more than 10mg per day)
- Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes (within the past 30 days).
- Subject has been treated with hyperbaric oxygen, wound VAC or Ozone gas(O3) within the past 5 days or is scheduled to receive during the study
Sites / Locations
- Emek Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ActiGraft
Arm Description
Whole blood clot (WBC) gel
Outcomes
Primary Outcome Measures
Percent of Reduction in Wound Size Over 12 Weeks
The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage.
Secondary Outcome Measures
Number of Participants Achieving a Complete Wound Closure at 12 Weeks
Skin re-epithelialization without drainage or dressing requirements.
Number of Participants Achieving a Complete re-epithelialization at 18 and 24 Weeks
Skin re-epithelialization without drainage or dressing requirements.
Percent of Reduction in Wound Size Over 18 and 24 Weeks.
The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage for wound treated beyond 12 weeks, per the investigator's decision
The change in wound pain by 12 weeks
Pain assessment would be done by using the Numeric Rating Scale (NRS). Subject chooses a number on a 1 to 10 scale that best describes his ulcer pain, while 0 represents "No Pain" and 10- " Worst Pain Imaginable "test, a scale between .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04745806
Brief Title
Post Marketing Trial for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard To Heal Wounds
Official Title
A Prospective, Single Arm, Post Marketing Study for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard to Heal Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
April 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RedDress Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a prospective, single arm, post- marketing study. The subjects enrolled to the study will receive weekly applications of ActiGraft until complete healing or until investigator's decision that patient can no longer benefit from the study treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds
Keywords
Chronic, Ulcer, Lower extremity, DFU, VLU
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ActiGraft
Arm Type
Experimental
Arm Description
Whole blood clot (WBC) gel
Intervention Type
Device
Intervention Name(s)
ActiGraft
Intervention Description
Whole blood clot (WBC) gel
Primary Outcome Measure Information:
Title
Percent of Reduction in Wound Size Over 12 Weeks
Description
The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage.
Time Frame
4, 8, and 12 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Achieving a Complete Wound Closure at 12 Weeks
Description
Skin re-epithelialization without drainage or dressing requirements.
Time Frame
12 weeks
Title
Number of Participants Achieving a Complete re-epithelialization at 18 and 24 Weeks
Description
Skin re-epithelialization without drainage or dressing requirements.
Time Frame
18 and 24 weeks
Title
Percent of Reduction in Wound Size Over 18 and 24 Weeks.
Description
The change in wound area (decrease or increase) with respect to the area at baseline, expressed as a percentage for wound treated beyond 12 weeks, per the investigator's decision
Time Frame
18 and 24 weeks
Title
The change in wound pain by 12 weeks
Description
Pain assessment would be done by using the Numeric Rating Scale (NRS). Subject chooses a number on a 1 to 10 scale that best describes his ulcer pain, while 0 represents "No Pain" and 10- " Worst Pain Imaginable "test, a scale between .
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is ≥18 years of age
Patient with a chronic lower extremity ulcer (i.e DFU, VLU, …)
Ulcer duration >30 days.
Ulcer size decreased in less than 30% in the 14 days prior to enrollment, while treated with standard of care (or advanced treatment)
Subject must be willing to comply with the protocol including having blood drawn to create the ActiGraft
Subject can read and understand the Informed Consent form
Exclusion Criteria:
Presence of active underlying osteomyelitis.
Known malignancy in the reference wound bed or margins of the wound
Cannot withdraw blood in the required amount technically.
Subject is receiving (i.e., within the past 30 days) systemic steroids (more than 10mg per day)
Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes (within the past 30 days).
Subject has been treated with hyperbaric oxygen, wound VAC or Ozone gas(O3) within the past 5 days or is scheduled to receive during the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sahar Boostenay
Phone
+972544621243
Email
sboostenay@reddressmedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon Sirota
Phone
+972545800765
Email
sharon@reddress.co.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Sirota
Organizational Affiliation
RedDress Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Emek Medical Center
City
Afula
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rotem Swartzman
Phone
+972-52-5935391
Email
rotem_sw@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Aziz Shoufani, Dr. Med.
First Name & Middle Initial & Last Name & Degree
Tamar Halperin, Dr. Med.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The results will be part of several scientific publications.
IPD Sharing Time Frame
Upon publication.
Learn more about this trial
Post Marketing Trial for Evaluating the Effectiveness of ActiGraft in Treating Lower Extremity Hard To Heal Wounds
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